Non-Pharmacological Alternatives to Proton Pump Inhibitors: Comparative Clinical Effectiveness and Guidelines - Cadth
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CADTH RAPID RESPONSE REPORT: SUMMARY OF ABSTRACTS Non-Pharmacological Alternatives to Proton Pump Inhibitors: Comparative Clinical Effectiveness and Guidelines Service Line: Rapid Response Service Version: 1.0 Publication Date: May 11, 2018 Report Length: 8 Pages
Authors: Michelle Clark, Melissa Severn Cite As: Non-Pharmacological Alternatives to Proton Pump Inhibitors: Comparative Clinical Effectiveness and Guidelines . Ottawa: CADTH;2018 May . (CADTH rapid response report: summary of abstracts). Acknowledgments: Disclaimer: The inf ormation in this document is intended to help Canadian health care decision-makers, health care prof essionals, health sy stems leaders, and policy -makers make well-inf ormed decisions and thereby improv e the quality of health care serv ices . While patients and others may access this document, the document is made av ailable f or inf ormational purposes only and no representations or warranties are made with respect to its f itness f or any particular purpose. The inf ormation in this document should not be used as a substitute f or prof essional medical adv ice or as a substitute f or the application of clinical judgment in respect of the care of a particular patient or other prof essional judgment in any decision-making process. The Canadian Agency f or Drugs and Technologies in Health (CADTH) does not endorse any inf ormation, drugs, therapies, treatments, products, processes, or serv ic es. While care has been taken to ensure that the inf ormation prepared by CADTH in this document is accurate, complete, a nd up-to-date as at the applicable date the material was f irst published by CADTH, CADTH does not make any guarantees to that ef f ect. CADTH does not guarantee and is not responsible f or the quality , currency , propriety , accuracy, or reasonableness of any s tatements, information, or conclusions contained in any third-party materials used in preparing this document. The v iews and opinions of third parties published in this document do not necessarily state or ref lect those o f CADTH. CADTH is not responsible f or any errors, omissions, injury , loss, or damage arising f rom or relating to the use (or misuse) of any inf ormation, stateme nts, or conclusions contained in or implied by the contents of this document or any of the source materials. This document may contain links to third-party websites. CADTH does not hav e control ov er the content of such sites. Use of third-party sites is gov erned by the third-party website owners’ own terms and conditions set out f or such sites. CADTH does not make any guarantee with r espect to any inf ormation contained on such third-party sites and CADTH is not responsible f or any injury , loss, or damage suf f ered as a result of using such third -party sites. CADTH has no responsibility f or the collection, use, and disclosure of personal inf ormation by third-party sites. Subject to the af orementioned limitations, the v iews expressed herein are those of CADTH and do not necessarily represent the v iews of Canada’s f ederal, prov incial, or territorial gov ernments or any third party supplier of inf ormation. This document is prepared and intended f or use in the context of the Canadian health care sy stem. The use of this document ou tside of Canada is done so at the user’s own risk. This disclaimer and any questions or matters of any nature arising f rom or relating to the content or use (or misuse) of this document will be gov erned by and interpreted in accordance with the laws of the Prov ince of Ontario and the laws of Canada applicable therein, and all proceed ings shall be subject to the exclusiv e jurisdiction of the courts of the Prov ince of Ontario, Canada. The copy right and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document f or non-commercial purposes only , prov ided it is not modif ied when reproduced and appropriate credit is giv en to CADTH and its licensors. About CADTH: CADTH is an independent, not-f or-prof it organization responsible f or prov iding Canada’s health care decision-makers with objectiv e ev idence to help make inf ormed decisions about the optimal use of drugs, medical dev ices, diagnostics, and procedures in our health ca re sy stem. Funding: CADTH receiv es f unding f rom Canada’s f ederal, prov incial, and territorial gov ernments, with the exception of Quebec. SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors 2
Research Questions 1. What is the comparative clinical effectiveness of non-pharmacological or alternative interventions compared to proton pump inhibitors for patients with disorders of excessive acid secretion? 2. What are the evidence-based guidelines for non-pharmacological or alternative interventions for patient with excessive acid secretion? Key Findings One non-randomized study and three evidence-based guidelines were identified regarding the comparative clinical effectiveness of non-pharmacological or alternative interventions compared to proton pump inhibitors for patients with disorders of excessive acid secretion. Methods A limited literature search was conducted on key resources including PubMed, The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, a s well as a focused Internet search. No filters were applied to limit the retrieval by study type. The search was also limited to English language documents published between Jan 1, 2013 and Apr 30, 2018. Internet links were provided, where available. Selection Criteria One reviewer screened citations and selected studies based on the inclusion criteria presented in Table 1. Table 1: Selection Criteria Population Patients with disorders of excessive acid secretion (e.g., acid reflux, gastroesophageal reflux disease) Interventions Non-drug alternatives to proton pump inhibitors (PPIs) (i.e., lifestyle changes – e.g., avoidance of acidic foods, avoiding lying down after eating, avoiding tight fitting clothes, stopping smoking, elevation of the head and neck, eating smaller meals and chewing more thoroughly, losing weight) Comparators Q1: PPIs Q2: No comparator Outcomes Q1: Clinical effectiveness (e.g., change in symptoms), safety (e.g., adverse events) Q2: Evidence based guidelines Study Designs Health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, non- randomized studies, evidence-based guidelines SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors 3
Results Rapid Response reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta -analyses are presented first. These are followed by randomized controlled trials, non -randomized studies, and evidence-based guidelines. One non-randomized study and three evidence-based guidelines were identified regarding the comparative clinical effectiveness of non-pharmacological or alternative interventions compared to proton pump inhibitors for patients with disorders of excessive acid secretion and guidelines for management. No relevant health technology assessments, systematic reviews, or randomized controlled trials were identified. Additional references of potential interest are provided in the appendix. Overall Summary of Findings One non-randomized study1 compared the consumption of alkaline water and a mostly plant-based Mediterranean diet with standard reflux precautions with the use of proton pump inhibitors (PPIs) and standard reflux precautions for the management of laryngopharyngeal reflux. A greater percentage of patients in the diet group achieved a clinically meaningful reduction in the Reflux Symptoms Index, but the difference was not statistically significant. Despite the lack of a significant difference in outcome s between groups, the authors suggested that the dietary approach should be considered as an option for the treatment of reflux because of the lower cost and lack of adverse events when compared with PPIs.1 A guideline from the University of Michigan 2 recommends that patients be prescribed lifestyle interventions for the treatment of gastroesophageal reflux disease (GERD) including: smoking cessation, avoiding specific foods, avoiding large meals, and avoiding certain medications, but specifies that only the recommendations for weight los s and avoiding lying flat after meals are based on evidence-based data.2 A guideline for the management of GERD and dyspepsia in adults from the National Institute for Health and Care Excellence 3 recommends advice related to healthy eating, weight loss, an d smoking cessation should be provided to all patients seeking treatment for GERD. The American College of Gastroenterology4 recommends a number of lifestyle interventions for the management of GERD including weight loss for patients who are overweight, el evation of the head of the bed, and avoiding meals two to three hours before bedtime. References Summarized Health Technology Assessments No literature identified. Systematic Reviews and Meta-analyses No literature identified. Randomized Controlled Trials No literature identified. SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors 4
Non-Randomized Studies 1. Zalvan CH, Hu S, Greenberg B, Geliebter J. A Comparison of Alkaline Water and Mediterranean Diet vs Proton Pump Inhibition for Treatment of Laryngopharyngeal Reflux. JAMA Otolaryngol Head Neck Surg. 2017 Oct 1;143(10):1023-9. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710251 PubMed: PM28880991 Guidelines and Recommendations 2. Gastroesophageal reflux disease (GERD) [Internet]. Ann Arbor (MI): Regents of the University of Michigan; 2013 Sep. [cited 2018 May 11; content reviewd 2018 Mar]. Available from: https://www.med.umich.edu/1info/FHP/practiceguides/gerd/gerd.12.pdf 3. Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management [Internet]. London: The National Institute for Health and Care Excellence; 2014 Nov. [cited 2018 May 11]. (Clinical guideline [CG184]). Available from: https://www.nice.org.uk/guidance/cg184 See: 1.2.1, page 10 4. Katz PO, Gerson LB, Vela MF. Diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol [Internet]. 2013 [cited 2018 May 11];108:308 -28. Available from: https://gi.org/guideline/diagnosis-and-managemen-of-gastroesophageal-reflux- disease/ SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors 5
Appendix — Further Information Previous CADTH Reports 5. Proton Pump Inhibitors for Gastrointestinal Conditions: A Review of Clinical Effectiveness and Cost-Effectiveness [Internet]. Ottawa: CADTH; 2015 Jun 19. [cited 2018 May 11]. (Rapid response summary with critical appraisal). Available from: https://www.cadth.ca/proton-pump-inhibitors-gastrointestinal-conditions-review-clinical- effectiveness-and-cost 6. Proton Pump Inhibitors Cessation Programs: A Review of Clinical Effectiveness, Cost- effectiveness and Guidelines [Internet]. Ottawa: CADTH; 2014 Oct 2. [cited 2018 May 11]. (Rapid response summary with critical appraisal). Available from: https://www.cadth.ca/proton-pump-inhibitors-cessation-programs-review-clinical- effectiveness-cost-effectiveness-and Systematic Reviews and Meta-Analyses – No Comparison to PPIs 7. Casale M, Sabatino L, Moffa A, Capuano F, Luccarelli V, Vitali M, et al. Breathing training on lower esophageal sphincter as a complementary treatment of gastroesophageal reflux disease (GERD): a systematic review. Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4547-52. PubMed: PM27874942 8. Kang JH, Kang JY. Lifestyle measures in the management of gastro -oesophageal reflux disease: clinical and pathophysiological considerations. Ther Adv Chronic Dis. 2015 Mar;6(2):51-64. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4331235 PubMed: 25729556 Non-Randomized Studies Lifestyle Interventions in Combination with Pharmaceutical Interventions 9. Ong AM, Chua LT, Khor CJ, Asokkumar R, Namasivayam O, Wang YT. Diaphragmatic Breathing Reduces Belching and Proton Pump Inhibitor Refractory Gastroesophageal Reflux Symptoms. Clin Gastroenterol Hepatol. 2018 Mar;16(3):407-16. PubMed: PM29104130 10. Allampati S, Lopez R, Thota PN, Ray M, Birgisson S, Gabbard SL. Use of a positional therapy device significantly improves nocturnal gastroesophageal reflux symptoms. Dis Esophagus. 2017 Feb 1;30(3):1-7. PubMed: PM27629558 11. Haruma K, Kinoshita Y, Sakamoto S, Sanada K, Hiroi S, Miwa H. Lifestyle factors and efficacy of lifestyle interventions in gastroesophageal reflux disease patients with functional dyspepsia: primary care perspectives from the LEGEND study. Intern Med. 2015;54(7):695-701. PubMed: PM25832928 SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors 6
Not Compared with PPIs 12. Randhawa MA, Mahfouz SA, Selim NA, Yar T, Gillessen A. An old dietary regimen as a new lifestyle change for Gastro esophageal reflux disease: A pilot study. Pak J Pharm Sci. 2015 Sep;28(5):1583-6. PubMed: PM26408867 Clinical Practice Guidelines – Methodology Not Specified 13. Dagli U, Kalkan IH. The role of lifestyle changes in gastroesophageal reflux diseases treatment. Turk J Gastroenterol [Internet]. 2017 [cited 2018 May 11];28 (suppl 1):S33- S37. Available from: http://www.turkjgastroenterol.org/sayilar/303/buyuk/S33-S37.pdf 14. Richardson B. the role of nutrition in preventing and managing GERD. Nutrition & Foodservice EDGE [Internet]. 2017 [cited 2018 May 11];July - August. Available from: https://www.anfponline.org/docs/default-source/legacy-docs/docs/ce- articles/nc072017.pdf 15. Gastroesophageal reflux disease (GERD) [Internet]. Portland (OR): The Portland Clinic; 2013. [cited 2018 May 11]. Available from: http://www.theportlandclinic.com/wp- content/uploads/2017/01/10560-Gastroesophageal-Reflux-Disease.pdf Review Articles 16. Chuang TW, Chen SC, Chen KT. Current status of gastroesophageal reflux disease : diagnosis and treatment. Acta Gastroenterol Belg. 2017 Jul;80(3):396-404. PubMed: PM29560670 17. Patti MG. An Evidence-Based Approach to the Treatment of Gastroesophageal Reflux Disease. JAMA Surg. 2016 Jan;151(1):73-8. PubMed: PM26629969 18. Treating heartburn and gastro-esophageal relflux (GERD) [Internet]. Toronto: Choosing Wisely Canada; 2014 Oct 29. [cited 2018 May 11]. Available from: https://choosingwiselycanada.org/wp-content/uploads/2017/05/GERD-EN.pdf Additional References 19. Kroch DA, Madanick RD. Medical Treatment of Gastroesophageal Reflux Disease. World J Surg. 2017 Jul;41(7):1678-84. PubMed: PM28321555 20. Keung C, Hebbard G. The management of gastro-oesophageal reflux disease. Aust Prescr. 2016 Feb;39(1):6-10. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4816873 PubMed: PM27041798 21. Badillo R, Francis D. Diagnosis and treatment of gastroesophageal reflux disease. World J Gastrointest Pharmacol Ther. 2014 Aug 6;5(3):105-12. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4133436 PubMed: PM25133039 SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors 7
22. Diet and gastroesophageal reflux disease (GERD) [Internet]. Downers Grove (IL): American Society for Gastrointestinal Endoscopy; 2014. [cited 2018 May 11]. Available from: https://www.asge.org/docs/default-source/about-asge/newsroom/doc- gerd_infographic_final.pdf SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors 8
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